World's first plant-based medical grade face mask authorized under EUA by U.S. FDA

News provided by

PADM Medical

Oct 13, 2022, 12:38 ET

WINNIPEG, MB, Oct. 13, 2022 /PRNewswire/ - PADM Medical PRECISION ECO™ Plant based procedural mask with earloops receives emergency use authorization (EUA) from the U.S. FDA – It is the world's first plant based procedural mask to receive EUA for use in medical and healthcare settings

PADM Medical Group of Companies (PADM Medical Canada and PADM Medical USA), a global leader in the design and development of sustainable medical consumables and eco-friendly sustainable medical products, announced today that it has received its Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA)1 to market PRECISION ECO™, the world's first plant based, procedural mask with ear loops for use in healthcare and medical settings2 in the United States of America3.

Billions of petroleum based, synthetic disposable surgical masks are discarded globally on an annual basis. Increasingly, governments and consumers are recognizing the environmental threats posed world-wide by this plastic pollution. Most disposable Personal Protective Equipment (PPE) consists of petroleum based, non-biodegradable polymers that can take up to 450 years to decompose in our landfills, rivers, lakes, and other natural environments.

PADM Medical's PRECISION ECO™ Plant Based procedural masks, made using ECOFUSE™ plant-based materials manufactured by Roswell Textiles from renewable crop resources, will help reduce the adverse impact on the environment of petroleum based, single use disposable face masks. The ECOFUSE™ materials are industrially compostable and by being plant based, help reduce the CO2 emissions of PRECISION ECO™ by approximately 55% compared to conventional petroleum-based masks. PRECISION ECO™ procedural masks generate carbon credits as a result of the net carbon reduction.

Additionally, the PRECISION ECO™ Compostable/Plant Based Procedural Mask with Earloops is a USDA Certified Biobased product under the USDA BioPreferred Program with a biobased content of 82%.

"The EUA on the PRECISION ECO™ product is a milestone. It is a reward to our commitment to making eco-conscious products to support the health and wellness of all individuals and our planet. This commitment drives us as a company as we continue to innovate for a greener and more sustainable world. We are working in collaboration with our global partners to develop the vast potential of our PRECISION ECO™ plant based/compostable masks." said Martin Petrak, PADM Medical Group CEO.

Derek Atkinson, VP of Business Development at TotalEnergies Corbion added: "We should not accept the limitations of the current way of doing things as being the only way. As we try to minimize the impact of our products on the environment, it is these developments that help us realize these ambitions." He continued, "as the supplier to PADM Medical Group of the high purity polylactic acid (Luminy® PLA) needed in the production of these groundbreaking biobased surgical masks, we are delighted to learn that PADM has succeeded in obtaining Emergency Use Authorization from the US FDA."

For more information about PADM Medical and PRECISION ECO™ visit: www.padmmedicalusa.com

About PADM Medical

PADM Medical Group (padmmedical.com) is a global leader in design and development of medical devices, specifically eco-friendly sustainable medical consumables, and products. PADM Medical Group is a wholly owned subsidiary of the PADM Group of Companies. The PADM organization is an operationally diverse entity with a defining focus and expertise in highly technical and advanced manufacturing.

About TotalEnergies Corbion

TotalEnergies Corbion (formerly known as Total Corbion PLA) is a global technology leader in Poly Lactic Acid (PLA) and lactide monomers. PLA is a biobased and biodegradable polymer made from annually renewable resources, offering a reduced carbon footprint versus traditional plastics. The Luminy® PLA portfolio, which includes both high heat and standard PLA grades, is an innovative material that is used in a wide range of markets from packaging to consumer goods, fibers and automotive. TotalEnergies Corbion, headquartered in the Netherlands, operates a 75,000 tons per year PLA production facility in Rayong, Thailand and has recently announced the intention to build a second plant in Grandpuits, France. The company is a 50/50 joint venture between TotalEnergies and Corbion. www.totalenergies-corbion.com 

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1 The product has not been FDA cleared or approved.
2 The product has been authorized by FDA under an EUA for use in healthcare settings by Health Care Practitioners (HCP) as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.
3 This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

SOURCE PADM Medical

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